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NCT00513695 · ClinicalTrials.gov registry record · Phase 2

Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer

A Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, sponsored by University of Washington.

Completed
Registry status
Phase 2
Development phase
68
Enrollment target
7
Study locations

NCT00513695 is a Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer that has completed, run by University of Washington. The registered enrollment target is 68 participants, below the 317-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (79% lower). The trial reports 7 study locations across 4 states.

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The verdict

NCT00513695, a Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 2
Development phase
68 participants
Enrollment target
7
Study locations

Study Summary

This phase II trial studies how well giving sunitinib malate together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib malate together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed

Conditions Studied

Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Male Breast Cancer Inflammatory Breast Cancer

Interventions

  • DRUG cyclophosphamide
  • DRUG paclitaxel
  • BIOLOGICAL filgrastim
  • DRUG doxorubicin hydrochloride
  • DRUG sunitinib malate

Study Locations (7)

Washington

  • Skagit Valley Hospital - Mount Vernon
  • Olympic Medical Center - Port Angeles
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle

Alaska

  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage

Arizona

  • Arizona Cancer Center - Tucson

Idaho

  • Saint Luke's Mountain States Tumor Institute - Boise

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2007-06
Est. Completion 2017-10-16
Phase Phase 2

Sponsor

University of Washington

1,048 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00513695

The ClinicalTrials.gov registry entry for NCT00513695 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 317-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (79% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Stage II Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00513695 reports 7 study locations spanning 4 distinct geographic areas - top geographies include Washington, Alaska, Arizona.

Frequently Asked Questions

What is clinical trial NCT00513695 about?

NCT00513695 is a clinical study titled "Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer". This phase II trial studies how well giving sunitinib malate together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes need...

What is the current status of trial NCT00513695?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2007-06. Estimated completion is 2017-10-16.

What conditions does trial NCT00513695 study?

This clinical trial studies the following conditions: Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Male Breast Cancer.

What interventions are being tested in trial NCT00513695?

The interventions under investigation include: cyclophosphamide (DRUG), paclitaxel (DRUG), filgrastim (BIOLOGICAL), doxorubicin hydrochloride (DRUG), sunitinib malate (DRUG).

Who is sponsoring clinical trial NCT00513695?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00513695 being conducted?

This trial has 7 study locations across Alaska, Arizona, Idaho, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.